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MAGiC Sweep™ EP Mapping Catheter

by Stereotaxis, Inc.

510(k) K250590

MAGiC Sweep™ EP Mapping Catheter is a Class II device made by Stereotaxis, Inc., cleared under FDA 510(k) K250590 on 23 Jul 2025, active as of 25 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250590 Date23 Jul 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DRF
Device class
Class II
Regulation
21 CFR Part 870.1220
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K250590

6 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250590
UDI-DISize and differences
MAGiC Sweep 181001
ACCESS POINT TECHNOLOGIES, INC.
181001 / 18100100818087022873
Catheter Gauge 8 Fr; Length 130 cm
On the market
MAGiC Sweep 181002
ACCESS POINT TECHNOLOGIES, INC.
181002 / 18100200818087022880
Catheter Gauge 8 Fr; Length 130 cm
On the market
MAGiC Sweep 181003
ACCESS POINT TECHNOLOGIES, INC.
181003 / 18100300818087022897
Catheter Gauge 8 Fr; Length 130 cm
On the market
MAGiC Sweep 181019
ACCESS POINT TECHNOLOGIES, INC.
181019 / 18101900818087023054
Catheter Gauge 8 Fr; Length 130 cm
On the market
MAGiC Sweep 181020
ACCESS POINT TECHNOLOGIES, INC.
181020 / 18102000818087023061
Catheter Gauge 8 Fr; Length 130 cm
On the market
MAGiC Sweep 181022
ACCESS POINT TECHNOLOGIES, INC.
181022 / 18102200818087023085
Catheter Gauge 8 Fr; Length 130 cm
On the market

Similar devices

Other devices filed under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording).

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